Healing of Mandibular Third Molar Extraction Sockets Using Platelet Concentrates and Photobiomodulation

NCT ID: NCT07324213

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-02

Study Completion Date

2024-12-20

Brief Summary

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Surgical removal of impacted mandibular third molars is a common procedure that may be associated with postoperative pain, swelling, limited mouth opening, and delayed bone healing. Various regenerative techniques are used to improve healing outcomes after tooth extraction.

This study evaluated whether autologous platelet concentrates (advanced platelet-rich fibrin \[A-PRF+\] and concentrated growth factors \[CGF\]) and photobiomodulation using low-level laser therapy can improve healing after mandibular third molar extraction.

Participants requiring surgical removal of a mandibular third molar were randomly assigned to one of six treatment groups. Depending on the group, patients received standard wound closure alone, photobiomodulation, placement of autologous platelet concentrates into the extraction socket, or a combination of platelet concentrates and photobiomodulation.

Postoperative pain, swelling, mouth opening, and early wound healing were assessed during the first postoperative week. Bone regeneration within the extraction socket was evaluated using radiological imaging several months after surgery.

All procedures used in this study are commonly applied in clinical practice and are considered safe. The results of this study may help identify the most effective approach to improve healing and reduce postoperative discomfort following mandibular third molar extraction.

Detailed Description

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Surgical extraction of impacted mandibular third molars frequently results in postoperative complications such as pain, edema, trismus, and delayed bone regeneration. Advances in regenerative medicine have introduced autologous platelet concentrates, including advanced platelet-rich fibrin (A-PRF+) and concentrated growth factors (CGF), which provide sustained release of growth factors that may enhance soft and hard tissue healing. Additionally, photobiomodulation using low-level laser therapy has been reported to reduce inflammation and stimulate tissue regeneration.

This single-center, randomized, single-blind clinical trial was conducted to evaluate the effectiveness of A-PRF+, CGF, and photobiomodulation, applied alone or in combination, in enhancing postoperative healing following mandibular third molar extraction.

A total of 122 generally healthy adult participants requiring surgical extraction of a partially or fully impacted mandibular third molar were enrolled. Participants were randomly allocated to one of six parallel study groups: standard extraction with primary wound closure (control), extraction with photobiomodulation, extraction with socket augmentation using A-PRF+, extraction with socket augmentation using CGF, extraction with A-PRF+ combined with photobiomodulation, or extraction with CGF combined with photobiomodulation. All surgical procedures were performed under standardized clinical conditions. Primary wound closure was attempted in all cases. Photobiomodulation was performed using a diode laser with a wavelength of 635 nm, power output of 100 mW, and energy density of 4 J/cm², applied at four points around the extraction socket. Autologous platelet concentrates were prepared from the patient's peripheral blood using standardized centrifugation protocols.

Clinical outcomes, including postoperative pain assessed using a visual analogue scale, facial swelling, mouth opening, and early wound healing, were evaluated at 1, 3, and 7 days after surgery. Radiological assessment of bone regeneration within the extraction socket was performed 3 to 4 months postoperatively using cone-beam computed tomography-based fractal dimension analysis.

The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. All participants provided written informed consent prior to enrollment. The findings of this study aim to contribute to the optimization of postoperative management following mandibular third molar extraction by identifying effective regenerative treatment strategies.

Conditions

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Impacted Mandibular Third Molar Alveolar Bone Loss Impacted Mandibular Third Molar Extraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were randomly assigned to one of six parallel intervention groups and received only the intervention allocated to their study arm.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants were not informed about the type of regenerative intervention applied. Due to the nature of the surgical procedures, care providers and investigators were not masked.

Study Groups

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Control - Standard Extraction

Participants underwent surgical extraction of an impacted mandibular third molar followed by standard primary wound closure without the use of platelet concentrates or photobiomodulation.

Group Type OTHER

Mandibular Third Molar Extraction With Primary Wound Closure

Intervention Type PROCEDURE

Surgical extraction of a partially or fully impacted mandibular third molar performed under standardized clinical conditions, followed by primary wound closure with sutures. This procedure was applied in all study arms.

Photobiomodulation

Participants underwent surgical extraction of an impacted mandibular third molar followed by primary wound closure and photobiomodulation using low-level laser therapy applied immediately after surgery and during follow-up visits.

Group Type OTHER

Mandibular Third Molar Extraction With Primary Wound Closure

Intervention Type PROCEDURE

Surgical extraction of a partially or fully impacted mandibular third molar performed under standardized clinical conditions, followed by primary wound closure with sutures. This procedure was applied in all study arms.

Photobiomodulation

Intervention Type OTHER

Adjunctive photobiomodulation performed using low-level laser therapy applied to the extraction site. The intervention was delivered immediately after surgery and during follow-up visits according to the study protocol.

A-PRF+

Participants underwent surgical extraction of an impacted mandibular third molar followed by placement of autologous advanced platelet-rich fibrin (A-PRF+) into the extraction socket prior to primary wound closure.

Group Type OTHER

Mandibular Third Molar Extraction With Primary Wound Closure

Intervention Type PROCEDURE

Surgical extraction of a partially or fully impacted mandibular third molar performed under standardized clinical conditions, followed by primary wound closure with sutures. This procedure was applied in all study arms.

Autologous Platelet Concentrates

Intervention Type BIOLOGICAL

Autologous platelet concentrates prepared from the participant's peripheral blood and placed into the extraction socket prior to primary wound closure. Advanced platelet-rich fibrin (A-PRF+) and concentrated growth factors (CGF) were obtained using standardized centrifugation protocols and used according to the allocated study arm.

CGF

Participants underwent surgical extraction of an impacted mandibular third molar followed by placement of autologous concentrated growth factors (CGF) into the extraction socket prior to primary wound closure.

Group Type OTHER

Mandibular Third Molar Extraction With Primary Wound Closure

Intervention Type PROCEDURE

Surgical extraction of a partially or fully impacted mandibular third molar performed under standardized clinical conditions, followed by primary wound closure with sutures. This procedure was applied in all study arms.

Autologous Platelet Concentrates

Intervention Type BIOLOGICAL

Autologous platelet concentrates prepared from the participant's peripheral blood and placed into the extraction socket prior to primary wound closure. Advanced platelet-rich fibrin (A-PRF+) and concentrated growth factors (CGF) were obtained using standardized centrifugation protocols and used according to the allocated study arm.

A-PRF+ Plus Photobiomodulation

Participants underwent surgical extraction of an impacted mandibular third molar followed by placement of autologous advanced platelet-rich fibrin (A-PRF+) into the extraction socket and adjunctive photobiomodulation using low-level laser therapy.

Group Type OTHER

Mandibular Third Molar Extraction With Primary Wound Closure

Intervention Type PROCEDURE

Surgical extraction of a partially or fully impacted mandibular third molar performed under standardized clinical conditions, followed by primary wound closure with sutures. This procedure was applied in all study arms.

Autologous Platelet Concentrates

Intervention Type BIOLOGICAL

Autologous platelet concentrates prepared from the participant's peripheral blood and placed into the extraction socket prior to primary wound closure. Advanced platelet-rich fibrin (A-PRF+) and concentrated growth factors (CGF) were obtained using standardized centrifugation protocols and used according to the allocated study arm.

Photobiomodulation

Intervention Type OTHER

Adjunctive photobiomodulation performed using low-level laser therapy applied to the extraction site. The intervention was delivered immediately after surgery and during follow-up visits according to the study protocol.

CGF Plus Photobiomodulation

Participants underwent surgical extraction of an impacted mandibular third molar followed by placement of autologous concentrated growth factors (CGF) into the extraction socket and adjunctive photobiomodulation using low-level laser therapy.

Group Type OTHER

Mandibular Third Molar Extraction With Primary Wound Closure

Intervention Type PROCEDURE

Surgical extraction of a partially or fully impacted mandibular third molar performed under standardized clinical conditions, followed by primary wound closure with sutures. This procedure was applied in all study arms.

Autologous Platelet Concentrates

Intervention Type BIOLOGICAL

Autologous platelet concentrates prepared from the participant's peripheral blood and placed into the extraction socket prior to primary wound closure. Advanced platelet-rich fibrin (A-PRF+) and concentrated growth factors (CGF) were obtained using standardized centrifugation protocols and used according to the allocated study arm.

Photobiomodulation

Intervention Type OTHER

Adjunctive photobiomodulation performed using low-level laser therapy applied to the extraction site. The intervention was delivered immediately after surgery and during follow-up visits according to the study protocol.

Interventions

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Mandibular Third Molar Extraction With Primary Wound Closure

Surgical extraction of a partially or fully impacted mandibular third molar performed under standardized clinical conditions, followed by primary wound closure with sutures. This procedure was applied in all study arms.

Intervention Type PROCEDURE

Autologous Platelet Concentrates

Autologous platelet concentrates prepared from the participant's peripheral blood and placed into the extraction socket prior to primary wound closure. Advanced platelet-rich fibrin (A-PRF+) and concentrated growth factors (CGF) were obtained using standardized centrifugation protocols and used according to the allocated study arm.

Intervention Type BIOLOGICAL

Photobiomodulation

Adjunctive photobiomodulation performed using low-level laser therapy applied to the extraction site. The intervention was delivered immediately after surgery and during follow-up visits according to the study protocol.

Intervention Type OTHER

Other Intervention Names

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Advanced Platelet-Rich Fibrin (A-PRF+) Concentrated Growth Factors (CGF)

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18 to 40 years.
* Indication for surgical extraction of a partially or fully impacted mandibular third molar.
* Generally healthy individuals without systemic diseases.
* Ability to provide written informed consent.
* Willingness to attend scheduled follow-up visits.

Exclusion Criteria

* Presence of systemic diseases or metabolic disorders.
* Pregnancy or breastfeeding.
* Smoking.
* Recent antibiotic therapy.
* Poor oral hygiene.
* Exceptionally difficult tooth position.
* Surgical procedure exceeding the expected duration.
* Inability to achieve primary wound closure.
* Failure to comply with follow-up visits.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wrocław Medical University

UNKNOWN

Sponsor Role collaborator

Medical Innovation Center Wroclaw

OTHER

Sponsor Role lead

Responsible Party

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Jakub Hadzik

Associate Professor, PhD, DSc (Med.), Specialist in Oral Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medyczne Centrum Innowacji Wrocław Sp. z o.o.

Wroclaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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KB7052019-UMW

Identifier Type: -

Identifier Source: org_study_id

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